Saturday, October 16, 2021

Novartis hits setback in bid to block Regeneron’s Eylea prefilled syringe as dual lawsuits drag on


Novartis won’t be able to block Regeneron’s popular Eylea prefilled syringe any time soon after a regulatory setback. But the Lucentis maker isn’t giving up on the patent fight that could shift the anti-VEGF competition between the two drugs.

The U.S. International Trade Commission (ITC) on Monday ended (PDF) an investigation into a Novartis complaint that sought to ban imports of Eylea’s prefilled syringe based on alleged patent infringement.

 The termination followed Novartis’ request to withdraw the complaint a month ago—two weeks before a trial in front of an administrative law judge—after the company received an unfavorable opinion from agency staffers.

Instead of pursuing a case at the ITC, Novartis is now making its arguments in federal court. Novartis alleges infringement on the prefilled syringe patent in a lawsuit filed in federal court in New York, while Regeneron has an antitrust complaint against the Swiss pharma in that state.

Before Novartis’ ITC retraction, reviewers at the agency’s Office of Unfair Import Investigations sided with Regeneron, noting that Novartis’ patent and related claims of infringing imports were invalid, according to a redacted document (PDF) prepared before the hearing. The ITC originally opened the case last July.

Staffers recommended to delay any import ban on Eylea prefilled syringes even if Novartis eventually won the case; they raised concerns over public access to the drug as Regeneron switches its production to the vial format.

RELATED: Novartis, Regeneron wage acrimonious patent fight over Eylea’s prefilled syringe

Eylea’s prefilled syringe has quickly gained popularity since its launch in late 2019. It helped the eye drug reach nearly $5 billion in 2020 U.S. sales, up 6.5% despite COVID-19’s hit to the ophthalmology market. By comparison, Lucentis generated CHF 1.4 billion ($1.5 billion) in the U.S. last year, Novartis’ marketing partner Roche reported.

Eylea’s multiple indications, plus its ability to extend treatment intervals, “now in a prefilled syringe for efficiency and throughput in the offices,” make it a top choice for doctors, especially during the pandemic, Regeneron’s commercial chief Marion McCourt said during a conference call in February.

RELATED: Regeneron shoots for longer Eylea dosing interval in diabetic retinopathy with NIH data

Meanwhile, Novartis’ Sandoz generics unit has simultaneously unveiled its phase 3 development plan for an Eylea biosimilar. The new trial, dubbed Mylight, will enroll patients with wet age-related macular degeneration and is aimed to confirm that the biosim has equivalent efficacy and comparable safety to the original Eylea. In a Monday note, SVB Leerink analyst Geoffrey Porges wrote that he expects an approval for the Novartis copycat in early 2024 if everything pans out.



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